The Janssen unit of Johnson & Johnson (NYSE:JNJ) announced that 72.7% of patients treated with its investigational bladder cancer therapy TAR-200 indicated no detectable evidence of cancer in a mid-stage trial.
TAR-200 is a drug delivery system designed to provide a sustained local release of chemotherapy gemcitabine for bladder urine.
The open-label SunRISe-1 study evaluated TAR-200 and anti-PD-1 monoclonal antibody cetrelimab in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer.
The study enrolled patients who were ineligible for or declined radical cystectomy, and its Cohorts 2 and 3 involved 23 and 24 evaluable patients who received TAR-200 and cetrelimab as single agents, respectively.
According to early data, 72.7% of patients treated with TAR-200 alone and 38.1% of those treated with cetrelimab achieved the primary endpoint of complete response. At a median follow-up of 10.6 months, 15 out of 16 responses in Cohort 2 were still ongoing, and the median duration of response (DOR) had not yet been reached.
Regarding safety, there were some treatment discontinuations due to adverse events linked to TAR-200. Overall, the incidence of Grade Three or higher adverse events (AEs) was low in the SunRISe-1 trial.
by: Seeking Alpha
published on Seeking Alpha